Senior Moulding Validation Engineer (Medtech)

Location: Newquay, United Kingdom. Limited overnight travel to manufacturing, supplier, and customer sites, typically within the UK and Europe.

Company

Cytiva is a hirify.global operating company providing life science, diagnostics, and biotechnology solutions that support biological research, vaccines, medicines, and cell and gene therapies.

What you will do

• Lead global product validation activities for injection mould tooling changes, including new tooling, transfers, refurbishment, repairs, and major modifications.
• Develop and execute validation strategies aligned with internal procedures, ISO 13485, FDA requirements, and quality management systems.
• Define validation scope, acceptance criteria, sample sizes, and statistical rationales for verification and validation activities.
• Review and approve validation protocols and reports, including supplier-generated dimensional studies, capability analyses, and technical justifications.
• Create project plans with suppliers, the Global Moulding Group, and manufacturing sites while coordinating multiple projects against quality, cost, and delivery commitments.
• Participate in continuous improvement projects and Kaizen events.

Requirements

• Degree in Engineering or Science, or equivalent relevant experience.
• Experience in a life science manufacturing company or similarly regulated industry.
• Demonstrated experience leading validation of injection-moulded products.
• Strong project management and stakeholder management skills.
• Experience with risk assessment and technical change-control validation techniques in a regulated industry, including ISO 13485.
• Strong understanding of statistical analysis, process capability, and validation methodologies.
• Ability to use structured problem-solving techniques to identify root causes and sustain improvements.
• Ability to prioritize, manage, and complete projects with limited direction, on time and in full.
• Valid driver’s license with an acceptable driving record.

Nice to have

• Ability to communicate effectively across multiple departments and functions.
• Knowledge of Lean Manufacturing concepts.
• Knowledge of Six Sigma and statistical tools.

Culture & Benefits

• Work within hirify.global’s continuous improvement system and a culture focused on belonging, collaboration, and tangible impact.
• Comprehensive benefits, including healthcare programs and paid time off.
• Work on solutions supporting biological research, vaccines, medicines, and cell and gene therapies.